Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml

Prothya Biosolutions

Status and phase: Completed; Phase 3

Conditions: Primary Immunodeficiency

Treatments: Drug: Intravenous immunoglobulin infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT01985373

MD2012.02

2012-005727-32 (EudraCT Number)

Details and patient eligibility

About

Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion with Nanogam 50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam 100 mg/ml (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of Sanquin.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary a- or hypogammaglobulinemia, particularly patients with XLA or CVID
• Stabilised on treatment with Nanogam 50 mg/ml with 2-4 weeks intervals in an hospital or at home and willing to be treated with 1 infusion of Nanogam 50 mg/ml and 4 infusions of Nanogam 100 mg/ml at the hospital
• A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose and frequency)
• Age >= 18 years
• The patient has signed the consent form

Exclusion criteria

• Known with allergic reactions against human plasma or plasma products
• Having an ongoing progressive disease, including HIV infection
• Pregnancy or lactation
• Known with insufficiency of coronary or cerebral circulation
• Having renal insufficiency (plasma creatinin > 115µmol/L)
• Having IgA deficiency and anti-IgA antibodies have been detected

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Intravenous immunoglobulin infusion

Experimental group

Description:

One intravenous infusion with Nanogam 50 mg/ml and 4 with Nanogam 100 mg/ml (0.2-0.8 g/kg)

Treatment:

Drug: Intravenous immunoglobulin infusion